E-alcohol Therapy - an Evaluation of Alcohol Therapy Delivered Via Video Conference

NCT ID: NCT03116282

Last Updated: 2024-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

365 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-22

Study Completion Date

2021-08-01

Brief Summary

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The study evaluates whether the introduction of e-alcohol therapy (alcohol therapy delivered via video conference) can break with some of the barriers related to alcohol treatment and thereby appeal to people with a problematic alcohol use (Alcohol Use Disorder Test score ≥ 8). The study aims to evaluate the effect of e-alcohol therapy on initiation, treatment compliance and alcohol intake as compared to treatment as usual .

Detailed Description

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Background: Only a small proportion of those who have a problematic alcohol use receive treatment and compliance is low among the few that undergo treatment. If treatment more easily can be combined with everyday life and break with some of the barriers related to stigma by having a broader appeal, more people with a problematic alcohol use may seek and complete treatment. Alcohol therapy conducted via video conference may be an attractive treatment option and effective in reducing alcohol intake among people with a problematic alcohol use who do not seek traditional treatment.

Objective: The aim of this trial is to evaluate whether people with a problematic alcohol use (Alcohol Use Disorder Test score ≥ 8), who enroll in alcohol therapy delivered via video conference to a greater extent initiate as well as comply with treatment and reduce their alcohol intake compared to people allocated to standard alcohol treatment.

Design: Randomized controlled trial

Participants: 375 Danish citizens above 18 years with a problematic alcohol use (Alcohol Use Disorder Test (AUDIT) score \>8).

Intervention: Participants are randomized to one of two groups:

1. Conversational therapy via video conference where participants are contacted by an alcohol therapist for the purpose of initiating a course of treatment where participants are not required to show up at a clinic.
2. Treatment as usual where participants receive contact information on their local alcohol treatment facility for the purpose of contacting the facility to initiate a face-to-face course of treatment at the clinic.

The allocation of participants to the intervention will be 1:1 to the intervention and the control group.

Methods: Data will be collected by questionnaire at baseline, 3 months and 12 months post randomization. Analyses will be intention to treat. Subgroup analysis will be conducted in relation to personal and demographic characteristics.

Process evaluation will be performed using a combination of questionnaires and qualitative interviews with participants, therapists and management at the clinics.

Conditions

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Problematic Alcohol Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention

Conversational therapy via video conference where participants are contacted by an alcohol therapist for the purpose of initiating a course of therapy where participants are not required to show up at a clinic.

Group Type EXPERIMENTAL

E-alcohol therapy

Intervention Type BEHAVIORAL

Conversational therapy sessions provided via video conference by a professional alcohol therapist.

Control

Treatment as usual where participants receive contact information on their local alcohol treatment facility for the purpose of contacting the facility to initiate a face-to-face course of treatment at the clinic.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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E-alcohol therapy

Conversational therapy sessions provided via video conference by a professional alcohol therapist.

Intervention Type BEHAVIORAL

Other Intervention Names

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Electronic alcohol therapy

Eligibility Criteria

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Inclusion Criteria

\- Problematic alcohol consumption (Alcohol Use Disorder Test score ≥ 8)

Exclusion Criteria

* Not legally able and willing to provide informed consent
* No provision of a functional e-mail address
* No provision of municipality of residence and phone number
* No access to a personal computer equipped with functional camera, audio equipment, and Internet access.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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TRYG Foundation

OTHER

Sponsor Role collaborator

Novavi Outpatient Clinics

UNKNOWN

Sponsor Role collaborator

University of Southern Denmark

OTHER

Sponsor Role lead

Responsible Party

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Kia Kejlskov Egan

PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Janne Tolstrup, Professor

Role: STUDY_DIRECTOR

University of Southern Denmark

Ulrik Becker, Professor

Role: STUDY_DIRECTOR

University of Southern Denmark

Locations

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National Institute of Public Health

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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Egan KK, Becker U, M Ller SP, Pisinger V, Tolstrup JS. Effectiveness of proactive video therapy for problematic alcohol use on treatment initiation, compliance, and alcohol intake: a randomised controlled trial in Denmark. Lancet Digit Health. 2024 Jun;6(6):e418-e427. doi: 10.1016/S2589-7500(24)00067-0.

Reference Type DERIVED
PMID: 38789142 (View on PubMed)

Other Identifiers

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63110-2179

Identifier Type: -

Identifier Source: org_study_id